Back to resultsStudy of the Use of LUMA Lightwire
Primary Purpose
Sinusitis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Functional Endoscopic Sinus Surgery with Balloon Dilatation
Sponsored by
About this trial
This is an interventional supportive care trial for Sinusitis focused on measuring sinusitis
Eligibility Criteria
Inclusion Criteria:
- patients needing endoscopic sinus surgery
- initial or previous sinus surgery subject will be included
Exclusion Criteria:
Sites / Locations
- Lahey Clinic
Outcomes
Primary Outcome Measures
Time, ease and accuracy of placement - compare accuracy of trans-illumination with fluoroscopy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00705237
Brief Title
Study of the Use of LUMA Lightwire
Official Title
LUMA Lightwire Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Terminated
Why Stopped
Insufficient findings for data analysis
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lahey Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study will evaluate the accuracy and ease of use of the LUMA light wire and whether trans-illumination of the sinuses is comparable to fluoroscopy during balloon dilation procedures.
Detailed Description
50 patients undergoing functional endoscopic with balloon dilatation sinus surgery will be studied using the light wire technology. This will be used as a guide for the surgeon to know when they are safely in the sinus by trans-illumination through the sinus wall prior to utilizing balloon dilation. Routine fluoroscopy will be used as well to verify the position of the wire, which is currently standard practice. The ease, time required, and accuracy of placement will be recorded for each case and compared to data previously collected when suing standard wire technology.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
sinusitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Functional Endoscopic Sinus Surgery with Balloon Dilatation
Intervention Description
Luma lightwire technology will be utilized in conjunction with fluoroscopy for patients with sinusitis undergoing functional endoscopic sinus surgery with balloon dilatation. Trans-illumination of the sinus will be compared to fluoroscopy for accuracy
Primary Outcome Measure Information:
Title
Time, ease and accuracy of placement - compare accuracy of trans-illumination with fluoroscopy
Time Frame
at conclusion of subject enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients needing endoscopic sinus surgery
initial or previous sinus surgery subject will be included
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Catalano, M.D.
Organizational Affiliation
Lahey Clinic Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the Use of LUMA Lightwire
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